DEVICE: STAT PROFILE (00385480379380)
Device Identifier (DI) Information
STAT PROFILE
CCX
In Commercial Distribution
37938
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution
37938
NOVA BIOMEDICAL CORPORATION
STAT PROFILE CCX HEMOLYZER TUBING HARNESS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated | A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at point-of-care in acute care settings, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGA | GLUCOSE OXIDASE, GLUCOSE |
JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
JPI | DEVICE, HEMATOCRIT MEASURING |
JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061830 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cb3be21f-109b-40be-adb4-4d390dc60441
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com